Transcript Document
International Partnership for Microbicides The State of Research and Development of Microbicides for the Prevention of HIV Brussels, 7 October 2005 Dr. Zeda Rosenberg What is a Microbicide? Substance that can substantially prevent or reduce transmission of HIV when applied to the vagina Could potentially be made in many forms: – gel or cream – sponge – film – suppository – ring or diaphragm Comprehensive Approaches to HIV/AIDS Prevention Prior to Exposure Prior to Exposure Vaccines Pre-exposure prophylaxis STI treatment Time of Exposure Point of Transmission Treatment and Care Male and female condoms Anti-retroviral therapies Anti-retroviral therapies (mother-to-child) Opportunistic infection therapies Behavior change Microbicides Basic care Microbicides offer a woman-initiated method to reduce HIV transmission Female Anatomy Uterus Sperm Front Back Uterus Cervix Bladder Cervical epithelium Pubic bone Urethra Cervix Vagina Fornix of vagina Exterior os Rectum Vaginal epithelium Vagina Fungi Candidiasis Protozoa Trichomonas Viruses HIV Human papilloma Cytomegalovirus Hepatitis Bacteria Neisseria gonorrhoeae Chiamydia trachomonas Treponema pallidum Haemophilus Lactobacillus Lumen Epithelium Stroma Drug Delivery Formulations Delivery of active – Cervix/Vagina - Lumen - Surface - Intracellular Application frequency – Duration of activity Cost Manufacturing ease Other functions – Anti-inflammatory – Anti-STD – Lubricating – Spermicidal Stability Aesthetics – Feel, taste, odor Drug Development Process Pre-clinical – formulation; in vitro and in vivo Safety trials – tens to hundreds of participants; drug absorption and distribution in the body; product delivery, dosage, and duration; tissue coverage and tolerability; male and female product use acceptability; male tolerance. Large-scale efficacy trials – multi-country; multi-site; thousands of women trial participants; conclusive effectiveness testing IPM Mission IPM’s mission is to prevent HIV transmission by accelerating the development and access of safe and effective microbicides for use by women in developing countries. Need for the IPM International organization dedicated to microbicide development Identify and support promising new MBC candidates through the development process Raise sufficient resources to fund rapid development of MBC candidates for product licensure Prepare for availability and adoption of microbicides in resource-poor areas Guiding Principles as a PDP Not business as usual Reduce time to licensure The faster MBC are approved, the faster women will have access to them Rapid development of safe and effective MBC means more lives saved Provide resources to MBC developers Infrastructure Financial Identify best practices from both public and private sectors Collaborate with both public and private sector partners Maintain open dialogue with communities Protect women’s health Opportunities For Action Pipeline IPM Involvement Primary Supporter Polymers Cyanovirin CCR5 Blockers TMC 120 Supporting In Conversation Polymers Soluble DC SIGN CAP BMS 806 EMPRO Molecules Merck 167 BMS 806 CCR5 Blockers Imquest Library Merck 167 PMPA UC 781 PMPA UC 781 Imquest Library •Other candidates also exist including many proteins with multiple mechanisms of action, other redundant small molecules including NNRTI’s and NRTIs’ Donors Canada Denmark European Commission Ireland Norway The Netherlands Sweden United Kingdom United States The Bill and Melinda Gates Foundation The Rockefeller Foundation World Bank UNFPA International IPM Collaborators R&D collaborators include: St. George’s Hospital Medical School, UK GlaxoSmithKline, UK Warner Chilcott, Northern Ireland office Queen’s University, Ireland Tibotec-Virco, Belgium European Microbicide Project Clinical and Regulatory Affairs collaborators include: Medisearch International, Belgium University of the Witwatersrand, South Africa International Antiviral Therapy Evaluation Center, Netherlands World Health Organization Triclinium, South Africa FARMOVS-Parexel, South Africa / Multinational Access collaborators include: Health and Development Africa, South Africa JHPIEGO, Zambia Funding for Microbicides Funding in 2004 – US $140 million Ireland $3 million Advocacy $65 million Research Other European Commission Netherlands UK United States Bill and Melinda Gates Foundation NIH – 71% USAID – 25% CDC – 4% $72 million development Cost and Financial Gap In 2004, US$140 million was spent on microbicide research, development and advocacy $65 million on research + $72 million on development + $3 million on advocacy In 2005 and subsequent five years, this amount must increase to US$280 million $130 million on research + $120 million on development + $20 million on site development + $10 million on advocacy Conclusion With leadership, sufficient financial resources, collaborative efforts and product development expertise, women in developing countries should have access to effective microbicides within the next 5 to 10 years. Contact Information Visit our website at: www.ipm-microbicides.org Ms. Tessa Mattholie, European Liaison Officer Telephone: +32 (0)2-507-1224 Email: [email protected]